2019 lumason ultrasound contrast agent …...serious cardiopulmonary reactions, including...

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2019 LUMASON ® ULTRASOUND CONTRAST AGENT REIMBURSEMENT RESOURCE KIT DISCLAIMERS The information provided here is general reimbursement information for LUMASON. It is not legal advice, nor is it advice about how to code, complete, or submit any particular claim for payment. Although we supply this information based on our current knowledge, it is always the provider’s responsibility to determine and submit appropriate codes, charges, modifiers, and bills for the services that were rendered. This coding and reimbursement information is subject to change without notice. Payers or their local branches may have their own coding and reimbursement requirements and policies. Before filing any claims, providers should verify current requirements and policies with the payer. CPT ® copyright 2018 American Medical Association (AMA). All rights reserved. Fee schedules, relative value units, conversion factors, and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. CPT is a registered trademark of the American Medical Association.

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Page 1: 2019 LUMASON ULTRASOUND CONTRAST AGENT …...Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast

2019 LUMASON® ULTRASOUND CONTRAST AGENT

REIMBURSEMENT RESOURCE KIT

DISCLAIMERS

The information provided here is general reimbursement information for LUMASON. It is not legal advice, nor is it advice about how to code, complete, or submit any particular claim for payment. Although we supply this information based on our current knowledge, it is always the provider’s responsibility to determine and submit appropriate codes, charges, modifiers, and bills for the services that were rendered. This coding and reimbursement information is subject to change without notice. Payers or their local branches may have their own coding and reimbursement requirements and policies. Before filing any claims, providers should verify current requirements and policies with the payer.

CPT® copyright 2018 American Medical Association (AMA). All rights reserved. Fee schedules, relative value units, conversion factors, and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

CPT is a registered trademark of the American Medical Association.

Page 2: 2019 LUMASON ULTRASOUND CONTRAST AGENT …...Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast

CONTENTS

LUMASON indications ............................................................................................................................................ 3

Coding nomenclature ............................................................................................................................................ 4

- CPT® & HCPCS codes ............................................................................................................................................ 5

LUMASON Pass-Through Payment—HOPPS (hospital out-patient clinics) .......................................................... 6

- Sample hospital setting billing form UB-04 CMS-1450 .......................................................................................... 7

Medicare National Average Payment Rates for HOPPS (hospital out-patient clinics) ........................................ 8

- Echocardiography: C-codes ................................................................................................................................... 8

- Echocardiography: cross-walk codes with and without contrast ............................................................................ 8

- Echocardiography: CPT® codes ............................................................................................................................. 9

- Ultrasound of the liver and urinary tract C-code and CPT® codes ......................................................................... 10

Physician office & IDTF billing ........................................................................................................................... 11

- Sample physician billing global non-hospital outpatient setting CMS-1500 .......................................................... 13

Medicare National Average Payment Rates for physician office/IDTF ....................................................... 12

- Echocardiography ............................................................................................................................................... 12

- Ultrasound of the liver and urinary tract ............................................................................................................... 12

Hospital in-patient billing and coverage .......................................................................................................... 14

Reimbursement hotline ....................................................................................................................................... 15

LUMASON ordering information ......................................................................................................................... 16

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LUMASON is the only ultrasound contrast agent with 3 indications:1

Echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with suboptimal echocardiograms

Ultrasonography of the liver for the characterization of focal liver lesions in adult and pediatric patients

Ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients

INDICATIONS AND USAGE1

LUMASON is an ultrasound contrast agent indicated for use:• in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with

suboptimal echocardiograms• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patientsCONTRAINDICATIONS1

LUMASON is contraindicated in patients with:• history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1)].1

Please see full Prescribing Information for LUMASON ultrasound contrast agent including boxed WARNING at http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-informationYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS CARDIOPULMONARY REACTIONSSerious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)]. • Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)]. • Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].

LUMASON INDICATIONS

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Using the correct codes is the first step to support correct reimbursementProcedures must be coded correctly in order to obtain appropriate reimbursement from both CMS and commercial payers. The following describes the types of codes that may be applied when submitting claims for echocardiography, ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients, or ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients.

CPT® (Current Procedural Terminology) Codes used to report the service or procedure performed.

HCPCS (Healthcare Common Procedure Coding System) Codes used to report the provision of supplies, materials, injections, and certain services and procedures. For example, the HCPCS code for LUMASON is Q9950.

C-codes Unique, temporary HCPCS codes created by Medicare and used for HOPPS only. This is often done when no other appropriate code exists. An example of this is the C-code series in echocardiography, which are described on page 8.

ICD-10 (International Classification of Disease) Codes used to describe a patient’s signs and symptoms that would represent a medically necessary reason for performing the procedure. ICD-10 codes need to be entered on the claim form. ICD-10 is the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD), a medical classification list by the World Health Organization (WHO).

APC (Ambulatory Payment Classification) In most cases, the unit of payment under the HOPPS is the APC. CMS assigns individual services HCPCS & CPT codes to APCs based on similar clinical characteristics and similar costs. The payment rate and copayment calculated for an APC apply to each service within the APC. In 2019 CMS did not make changes to the APC structure from 2018.

NDC (National Drug Code) An NDC code provides a unique identifier for a specific drug. The NDC for LUMASON is: 0270-7099-16.

Medicare Addendum B These files are updated quarterly and reflect hospital HOPPS payment rates for HCPCS codes and APC codes. This is also where the Pass-Through code for LUMASON (Q9950) can be found: www.cms.gov/Medicare/Medicare-Fee-For-Service-Payment/HospitalOutpatientpps/Addendum-A-and-Addendum-B-Updates.html.

Medicare Part B ASP (average selling price) file Quarterly payment files are published for independent diagnostic testing facilities (IDTFs) and physician offices. This is where the payment value for LUMASON (Q9950) can be found: www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/index.html.

Medicare Physician Fee Schedule (MPFS) Find out physician payment for specific geographic locations in the country for different procedures. This schedule provides: global (G), technical (TC), and professional (26) component payment rates. See MEDICARE NATIONAL AVERAGE PAYMENTS FOR PHYSICIAN OFFICE/IDTFs chart for echocardiography and ultrasound procedures covered on page 12 of this guide. To find out more information on specific locations visit: www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PFSLookup/index.html?redirect=/pfslookup.

INDICATIONS AND USAGE1

LUMASON is an ultrasound contrast agent indicated for use:• in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with

suboptimal echocardiograms• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patientsCONTRAINDICATIONS1

LUMASON is contraindicated in patients with:• history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1)].1

Please see full Prescribing Information for LUMASON ultrasound contrast agent including boxed WARNING at http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-informationYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS CARDIOPULMONARY REACTIONSSerious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)]. • Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)]. • Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].

CODING NOMENCLATURE

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CPT®/HCPCS codes Description

Q9950: LUMASON Ultrasound contrast agent. 1 vial= 5 mL Billing unit is per mL New October 1, 2018: Pass-Through payment is back for 2 years2

Descriptor: Sulfur hexafluoride lipid microspheres, per mL; there are 5 mL per single-use vial of LUMASON.HOPPS: Medicare patients: LUMASON is separately payable because of its Pass-Through payment status. Code separately with the echocardiography and abdominal/ retroperitoneal procedures codes. The ASP or payment rate for the Pass-Through payment is updated on a quarterly basis in the Medicare Addendum B: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Addendum-A-and-Addendum-B-Updates.html. Commercially insured patients: it may be paid separately; it is based on provider contracts.Physician office/IDTF: Medicare patients: LUMASON is billed and paid separately. Refer to the Medicare Part B drug ASP file for the current quarterly payment value: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2019ASPFiles.html. Use of JW modifier: Since Jan. 1, 2017, CMS requires the use of the JW modifier to indicate the number of mL or units discarded for single-use vial drugs that are paid separately. See an example of billing on page 7 and 13.Commercially insured patients: the provider needs to contact their respective insurance providers to include Q9950 and establish a reimbursement value.

Echocardiography procedure codes3,4

See chart Echocardiography: Cross Walk Codes Without and With Contrast on page 8 of this guide

933xx series and C-8921-30 series Note that the C-codes series is for HOPPS only and generally for Medicare patients

Some commercial payers may accept C-codes. Providers need to check with their contracts. If not – use the 933xx series

CPT® & HCPCS codesThe following chart displays codes for procedures using LUMASON.

New January 1 2019!

Ultrasonography of the liver and the urinary tract for vesicoureteral reflux3

CPT® codes Description

76978 Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-cardiac); initial lesion

+76979, add-on code Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-cardiac); each additional lesion with separate injection (List separately in addition to code for primary procedure)

INDICATIONS AND USAGE1

LUMASON is an ultrasound contrast agent indicated for use:• in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with

suboptimal echocardiograms• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patientsCONTRAINDICATIONS1

LUMASON is contraindicated in patients with:• history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1)].1

Please see full Prescribing Information for LUMASON ultrasound contrast agent including boxed WARNING at http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-informationYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS CARDIOPULMONARY REACTIONSSerious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)]. • Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)]. • Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].

CODING NOMENCLATURE (cont’d)

Page 6: 2019 LUMASON ULTRASOUND CONTRAST AGENT …...Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast

In accordance with Public Law 115-141, LUMASON ultrasound contrast agent is receiving Pass-Through Payment Status for 2 years effective October 1, 2018 until September 30, 20202

Payment in an outpatient hospital clinic is based on a prospective payment system. The system is based on groups of procedures, medical visits, and ancillary services. Under the HOPPS system, contrast agents are not separately payable; rather, they are packaged or bundled with the procedure.

However, there is an exception in the case of LUMASON, because of its Pass-Through payment status. A Pass-Through payment status means that a temporary additional HOPPS payment is made for innovative devices, drugs, and biologicals for Medicare beneficiaries. It is not subject to coinsurance or packaging rules.2

As of October 1, 2018, the value of the Pass-Through payment is $21.25 per mL and equivalent to $106.25 /vial. Stay up to date by visiting Medicare Addendum B website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Addendum-A-and-Addendum-B-Updates.html.

In MLN Matters® MM10923 and related transmittal R4123CP, CMS states that an APC offset will be applied to Level 2 and Level 3 imaging with contrast procedures. See Table 1 for the procedure codes affected by the offset.2 Since January 1, 2017, Medicare requires the use of the JW modifier to indicate the amount of discarded drug/product from a single-use vial. For more information: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/JW-Modifier-FAQs.pdf.

It is important to code Q9950 and all the mL used and discarded for a total of 5 mL per vial to benefit from the Pass-Through payment along with the specific procedure performed.

2019 HOPPS APC & Procedure Code (Ambulatory Payment Classification) Procedure short desciption

2019 Medicare National Average for bundled procedure

Pass Through Payment for Q9950 -LUMASON®

Contrast Agent1

Estimated APC offset value based on Medicare National

payment average2

HCPCS Description

5571 Level 1 Imaging with Contrast $201.74 $ 21.25/ ml or $106.25 a vial n/a

76978 US trgt dyn mbubb 1st lesion

5572* Level 2 Imaging with Contrast $385.88 $ 21.25/ ml or $106.25 a vial $46.72

C8924 2D TTE w or w/o fol w/con, fu

5573* Level 3 Imaging with Contrast $691.75 $ 21.25/ ml or $106.25 a vial $96.01

C8921 Tte w or w/o fol w/cont, co

C8922 Tte w or w/o fol w/cont, f/

C8923 2d tte w or w/o fol w/con,c

C8925 2d tee w or w/o fol w/con,i

C8926 Tee w or w/o fol w/cont,con

C8927 Tee w or w/o fol w/cont, mo

C8928 Tte w or w/o fol w/con,stre

C8929 Tte w or wo fol wcon,dopple

C8930 Tte w or w/o contr, cont ec

* MLN Matters® MM10923 table 4: APC’s with new Payment Rates because of the Separate payment for certain drugs and biologicals receiving Pass-Through Status in accordance with Public Law 115-141.

1. Addendum B: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Addendum-A-and-Addendum-B-Updates.html2. APC offset file 2019: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Annual-Policy-Files-Items/2019-Annual-Policy-Files.html

Each mL of LUMASON is billable

Table 1: Level 2 and Level 3 Imaging with Contrast APC’s and Procedure codes affected by offset2

INDICATIONS AND USAGE1

LUMASON is an ultrasound contrast agent indicated for use:• in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with

suboptimal echocardiograms• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patientsCONTRAINDICATIONS1

LUMASON is contraindicated in patients with:• history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1)].1

Please see full Prescribing Information for LUMASON ultrasound contrast agent including boxed WARNING at http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-informationYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS CARDIOPULMONARY REACTIONSSerious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)]. • Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)]. • Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].

6

* MLN Matters is a registered trademark of the U.S. Department of Health and Human Services. Agency of the United States Government. United States bldg. 31 Rm2B-50, 31 Center Bethesda, Maryland 208922111.

LUMASON Pass-Through Payment—HOPPS

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NUBC

67 DX

Hospital Name 2 Pay – To Name 3a PAT. CNTL #

b. MED. REC. #

5 FED. TAX NO.

6 STATEMENT COVERS PERIOD 7

FROM THR OUGH

4 TYPE OF BILL

8 PATIENT NAME a 9 PATIENT ADDRESS a

b b c d e

10 BIRTHDATE 11 SEX 12 DATE

ADMISSION 13 HR 14 TYPE 15 SRC

16 DHR 17 STAT CONDITION CODES

18 19 20 21 22 23 24 25 26 27

29 ACDT 30 28 STATE

31 OCCURRENCE 32 OCCURRENCE 33 OCCURRENCE 34 OCCURRENCE 35 OCCURRENCE SPAN 36 OCCURRENCE SPAN 37 CODE DATE CODE DATE CODE DATE CODE DATE CODE FROM THROUGH CODE FROM THROUGH

38 39 VALUE CODES 40 VALUE CODES 41 VALUE CODES CODE AMOUNT CODE AMOUNT CODE AMOUNT

a

b

c

d

42 REV. CD. 43 DESCRIPTION 44 HCPCS / RATE / HIPPS CODE

45 SERV. DATE 46 SERV. UNITS 47 TOTAL CHARGES 48 NON-COVERED CHARGES 49

1 2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

PAGE OF CREATION DATE

TOTALS

22

23

50 PAYER NAME 51 HEALTH PLAN ID 52 REL. 53 ASG. 54 PRIOR PAYMENTS 55 EST. AMOUNT DUE 56 NPI INFO BEN.

A

B

C

57 A OTHER B PRV ID C

58 INSURED’S NAME 59 P. REL 60 INSURED’S UNIQUE ID 61 GROUP NAME 62 INSURANCE GROUP NO.

A A

B B

C C

63 TREATMENT AUTHORIZATION CODES 64 DOCUMENT CONTROL NUMBER 65 EMPLOYER NAME

A A

B B

C C

66 A B C D E F G H 68

I J K L M N O P Q 69 ADMIT 70 PATIENT

DX REASON DX a b c 71 PPS CODE

72 73 ECI

74 PRINCIPAL PROCEDURE a. OTHER PROCEDURE b. OTHER PROCEDURE 75 CODE DATE CODE DATE CODE DATE 76 ATTENDING

LAST

NPI QUAL FIRST

c. OTHER PROCEDURE d. OTHER PROCEDURE e. OTHER PROCEDURE 77 OPERATING

NPI

QUAL

CODE DATE

80 REMARKS

CODE DATE

81CC

a

CODE DATE LAST 78 OTHER

NPI

FIRST

QUAL

b LAST FIRST

c 79 OTHER NPI

QUAL

UB-04 CMS-1450

APPROVED OMB NO.

d LAST FIRST

THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF. ™

National Uniform Billing Committee

LIC9213257

0483 Echocardiography 0636 LUMASON® Inj. Sulf hexa lipid microsphere /mL

C8929 Q9950 Q9950 - JW

10/01/2018 10/01/2018 10/01/2018

1 3 2

xxxx.xx xxx.xx xxx.xx

Form Locator 42 (Rev. CD) Enter Revenue Code: 0254 Drugs incident to diagnostic service 0636 Drugs requiring detailed coding (Verify Revenue Code with Hospital Billing Department and Insurance Providers)

Form Locator 44 (HCPCS/Rates/HIPPS Code) Enter CPT© or HCPCS code for procedure and radiopharmaceutical C8929 Echocardiography Q9950 LUMASON® (Retains Pass-Through status until Sept. 2020)

Form Locator 46 (Units of Service) Enter number of units based on the HCPCS descriptor

Bracco Diagnostics Inc. cannot guarantee coverage or payment for products or procedures at any particular level. For more specific information please contact your Medicare contractor or the patient’s insurer.

JW ModifierApplied to the amount ofcontrast drug that is discarded

Sample hospital setting billing form UB-04 CMS-1450Echocardiography with LUMASON

INDICATIONS AND USAGE1

LUMASON is an ultrasound contrast agent indicated for use:• in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with

suboptimal echocardiograms• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patientsCONTRAINDICATIONS1

LUMASON is contraindicated in patients with:• history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1)].1

Please see full Prescribing Information for LUMASON ultrasound contrast agent including boxed WARNING at http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-informationYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS CARDIOPULMONARY REACTIONSSerious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)]. • Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)]. • Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].

LUMASON Pass-Through Payment—HOPPS (cont’d)

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HCPCS code Long-description HCPCS

2019 HOPPS National

Payment Rate - HCPCS5

C8921 Transthoracic echocardiography with contrast, or without contrast followed by with contrast, for congenital cardiac anomalies; complete $691.75

C8922 Transthoracic echocardiography with contrast, or without contrast followed by with contrast, for congenital cardiac anomalies; follow-up or limited study $691.75

C8923Transthoracic echocardiography with contrast, or without contrast followed by with contrast, real-time with image documentation (2d), includes m-mode recording, when performed, complete, without spectral or color doppler echocardiography

$691.75

C8924 Transthoracic echocardiography with contrast, or without contrast followed by with contrast, real-time with image documentation (2d), includes m-mode recording, when performed, follow-up or limited study $385.88

C8925 Transesophageal echocardiography (TEE) with contrast, or without contrast followed by with contrast, real time with image documentation (2d) (with or without m-mode recording); including probe placement, image acquisition, interpretation and report $691.75

C8926 Transesophageal echocardiography (TEE) with contrast, or without contrast followed by with contrast, for congenital cardiac anomalies; including probe placement, image acquisition, interpretation and report $691.75

C8927

Transesophageal echocardiography (TEE) with contrast, or without contrast followed by with contrast, for monitoring purposes, including probe placement, real time 2-dimensional image acquisition and interpretation leading to ongoing (continuous) assessment of (dynamically changing) cardiac pumping function and to therapeutic measures on an immediate time basis

$691.75

C8928Transthoracic echocardiography with contrast, or without contrast followed by with contrast, real-time with image documentation (2d), includes m-mode recording, when performed, during rest and cardiovascular stress test using treadmill, bicycle exercise and/or pharmacologically induced stress, with interpretation and report

$691.75

C8929Transthoracic echocardiography with contrast, or without contrast followed by with contrast, real-time with image documentation (2d), includes m-mode recording, when performed, complete, with spectral doppler echocardiography, and with color flow doppler echocardiography

$691.75

C8930

Transthoracic echocardiography, with contrast, or without contrast followed by with contrast, real-time with image documentation (2d), includes m-mode recording, when performed, during rest and cardiovascular stress test using treadmill, bicycle exercise and/or pharmacologically induced stress, with interpretation and report; including performance of continuous electrocardiographic monitoring, with physician supervision

$691.75

Echocardiography: C-codes4

Echocardiography: Cross Walk Codes Without and With Contrast3,4

CPT C-code

93303 C8921

93304 C8922

93306 C8929

93307 C8923

93308 C8924

without contrast with contrast CPT C-code

93312 C8925

93315 C8926

93318 C8927

93350 C8928

93351 C8930

without contrast with contrast

INDICATIONS AND USAGE1

LUMASON is an ultrasound contrast agent indicated for use:• in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with

suboptimal echocardiograms• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patientsCONTRAINDICATIONS1

LUMASON is contraindicated in patients with:• history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1)].1

Please see full Prescribing Information for LUMASON ultrasound contrast agent including boxed WARNING at http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-informationYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS CARDIOPULMONARY REACTIONSSerious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)]. • Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)]. • Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].

MEDICARE NATIONAL AVERAGE PAYMENT RATES FOR HOPPS

Page 9: 2019 LUMASON ULTRASOUND CONTRAST AGENT …...Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast

9

CPT® code Long-description CPT®

2019 HOPPS National Payment

Rate - CPT®5

93303 Transthoracic echocardiography for congenital cardiac anomalies; complete $497.49

93304 Transthoracic echocardiography for congenital cardiac anomalies; follow-up or limited study $497.49

93306 Echocardiography, transthoracic, real-time with image documentation (2d), includes m-mode recording, when performed, complete, with spectral doppler echocardiography, and with color flow doppler echocardiography $497.49

93307 Echocardiography, transthoracic, real-time with image documentation (2d), includes m-mode recording, when performed, complete, without spectral or color doppler echocardiography $230.56

93308 Echocardiography, transthoracic, real-time with image documentation (2d), includes m-mode recording, when performed, follow-up or limited study $230.56

93312 Echocardiography, transesophageal, real-time with image documentation (2d) (with or without m-mode recording); including probe placement, image acquisition, interpretation and report $497.49

93313 Echocardiography, transesophageal, real-time with image documentation (2d) (with or without m-mode recording); placement of transesophageal probe only $497.49

93314 Echocardiography, transesophageal, real-time with image documentation (2d) (with or without m-mode recording); image acquisition, interpretation and report only packaged

93315 Transesophageal echocardiography for congenital cardiac anomalies; including probe placement, image acquisition, interpretation and report $497.49

93316 Transesophageal echocardiography for congenital cardiac anomalies; placement of transesophageal probe only $497.49

93317 Transesophageal echocardiography for congenital cardiac anomalies; image acquisition, interpretation and report only packaged

93318Echocardiography, transesophageal (TEE) for monitoring purposes, including probe placement, real time 2-dimensional image acquisition and interpretation leading to ongoing (continuous) assessment of (dynamically changing) cardiac pumping function and to therapeutic measures on an immediate time basis

$497.49

93350Echocardiography, transthoracic, real-time with image documentation (2d), includes m-mode recording, when performed, during rest and cardiovascular stress test using treadmill, bicycle exercise and/or pharmacologically induced stress, with interpretation and report;

$497.49

93351

Echocardiography, transthoracic, real-time with image documentation (2d), includes m-mode recording, when performed, during rest and cardiovascular stress test using treadmill, bicycle exercise and/or pharmacologically induced stress, with interpretation and report; including performance of continuous electrocardiographic monitoring, with supervision by a physician or other qualified health care professional

$497.49

93352 Use of echocardiographic contrast agent during stress echocardiography (list separately in addition to code for primary procedure) not paid under OPPS

93355

Echocardiography, transesophageal (TEE) for guidance of a transcatheter intracardiac or great vessel(s) structural intervention(s) (eg,tavr, transcathether pulmonary valve replacement, mitral valve repair, paravalvular regurgitation repair, left atrial appendage occlusion/closure, ventricular septal defect closure) (peri-and intra-procedural), real-time image acquisition and documentation, guidance with quantitative measurements, probe manipulation, interpretation, and report, including diagnostic transesophageal echocardiography and, when performed, administration of ultrasound contrast, doppler, color flow, and 3d

packaged

93320 Doppler echocardiography, pulsed wave and/or continuous wave with spectral display (list separately in addition to codes for echocardiographic imaging); complete packaged

Add-on code, use 93320 in conjunction with 93303, 93304, 93312, 93314, 93315, 93317, 93350, 93351, C8921, C8922, C8925, C8926, C8928, C8930

93321 Doppler echocardiography, pulsed wave and/or continuous wave with spectral display (list separately in addition to codes for echocardiographic imaging); follow-up or limited study (list separately in addition to codes for echocardiographic imaging) packaged

Add-on code, use 93321 in conjunction with 93303, 93304, 93308, 93312, 93314, 93315, 93317, 93350,93351, C8921, C8922, C8924, C8925, C8926, C8928, C8930

93325 Doppler echocardiography color flow velocity mapping (list separately in addition to codes for echocardiography) packaged

Add-on code, use 93325 in conjunction with 76825, 76826, 76827, 76828, 93303, 93304, 93308, 93312, 93314, 93315, 93317, 93350, 93351, C8921, C8922, C8924, C8925, C8926, C8928, C8930

Echocardiography CPT® codes3

INDICATIONS AND USAGE1

LUMASON is an ultrasound contrast agent indicated for use:• in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with

suboptimal echocardiograms• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patientsCONTRAINDICATIONS1

LUMASON is contraindicated in patients with:• history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1)].1

Please see full Prescribing Information for LUMASON ultrasound contrast agent including boxed WARNING at http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-informationYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS CARDIOPULMONARY REACTIONSSerious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)]. • Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)]. • Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].

MEDICARE NATIONAL AVERAGE PAYMENT RATES FOR HOPPS (cont’d)

Page 10: 2019 LUMASON ULTRASOUND CONTRAST AGENT …...Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast

10

New January 1 2019!

Ultrasonography of the liver and urinary tact for vesicoureteral reflux3

CPT® code Description 2019 HOPPS

National Payment Rate5

76978 Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-cardiac); initial lesion $201.74

+76979, add-on code Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-cardiac); each additional lesion with separate injection (List separately in addition to code for primary procedure) Packaged

INDICATIONS AND USAGE1

LUMASON is an ultrasound contrast agent indicated for use:• in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with

suboptimal echocardiograms• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patientsCONTRAINDICATIONS1

LUMASON is contraindicated in patients with:• history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1)].1

Please see full Prescribing Information for LUMASON ultrasound contrast agent including boxed WARNING at http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-informationYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS CARDIOPULMONARY REACTIONSSerious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)]. • Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)]. • Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].

! Note: C9744 is deleted as of December 31, 2018 and replaced by new CPT® codes in the chart4

HCPCS code Description

Q9950 Sulfur hexafluoride lipid microspheres, per mL; there are 5 mL per single-use vial of LUMASON. LUMASON is paid separately in HOPPS for Medicare patient due to its Pass-Through payment status - see p. 6 for more details2

LUMASON ultrasound contrast agent

MEDICARE NATIONAL AVERAGE PAYMENT RATES FOR HOPPS (cont’d)

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11

LUMASON ultrasound contrast agent is paid separately by Medicare Part BWhen an echocardiogram or other type of ultrasound exam is performed in the physician’s office or IDTF, LUMASON (Q9950) is paid separately by Medicare Part B and is reported along with the appropriate CPT® procedure code. Note that C-codes cannot be used in the physician office; C-codes are only for HOPPS. LUMASON (Q9950) contrast agent payment amounts are based on ASP (average selling price + 6%) and are reimbursed at the discretion of the Local Medicare Contractors (MAC). Payment rates are adjusted quarterly; please refer to the Medicare Part B ASP file at: www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/index.html. For the first quarter of the year the reimbursement value is: $20.346 per mL or $101.73 per vial.

LUMASON is a single-use vial. Medicare allows reimbursement for the amount injected and the amount discarded for single-use vials. Since January 1, 2017, the JW modifier is required on the claim form. The JW modifier documents the amount of a single-use vial that is discarded. LUMASON contains a total of 5 mL. For more information: www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/JW-Modifier-FAQs.pdf. See page 13 for an example of billing using the JW modifier.

For commercially insured patients: Commercial payers usually reimburse contrast agents separately in the physician office and IDTF setting. Providers need to verify their contracts to confirm coding, coverage, and payment amounts.

Medicaid patients: Bracco Diagnostics does not participate in the Medicaid rebate program. This means LUMASON is not paid separately.

Billing for the Procedure: The Medicare National Average payment rates for global (G), technical (TC), and professional (26) for the procedures are listed in: MEDICARE NATIONAL AVERAGE PAYMENTS FOR PHYSICIAN OFFICE/IDTF on page 12 of this guide, and can be found online for your specific geographic area at: www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PFSLookup/index.html?redirect=/pfslookup.

INDICATIONS AND USAGE1

LUMASON is an ultrasound contrast agent indicated for use:• in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with

suboptimal echocardiograms• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patientsCONTRAINDICATIONS1

LUMASON is contraindicated in patients with:• history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1)].1

Please see full Prescribing Information for LUMASON ultrasound contrast agent including boxed WARNING at http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-informationYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS CARDIOPULMONARY REACTIONSSerious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)]. • Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)]. • Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].

PHYSICIAN OFFICE & IDTF BILLING

Page 12: 2019 LUMASON ULTRASOUND CONTRAST AGENT …...Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast

12

CPT® Short descriptor Payment

93303 TC TTE limited congenital $174.43

93303 26 TTE limited congenital $65.63

93303 G TTE limited congenital $239.66

93304 TC TTE limited $125.78

93304 26 TTE limited $37.48

93304 G TTE limited $163.26

93306 TC TTE comp, Dop, CF $135.51

93306 26 TTE comp, Dop, CF $74.96

93306 G TTE comp, Dop, CF $210.47

93307 TC TTE comp, w/o Dop, CF $96.95

93307 26 TTE comp, w/o Dop, CF $46.13

93307 G TTE comp, w/o Dop, CF $143.08

93308 TC TTE F/U or limited $73.88

93308 26 TTE F/U or limited $26.31

93308 G TTE F/U or limited $100.19

93312 TC TEE place acq,int, rep. $139.11

93312 26 TEE place acq,int, rep. $112.08

93312 G TEE place acq,int, rep. $251.19

93314 TC TEE acq, inter, report $148.48

93314 26 TEE acq, inter, report $94.06

93314 G TEE acq, inter, report $242.54

CPT® Short descriptor Payment

93315 26 TEE cong. acq, inter, report $131.90

93317 26 TEE acq, inter, report only $95.14

93318 26 TEE monitoring $107.40

93320 TC Doppler echo $35.68

93320 26 Doppler echo $18.74

93320 G Doppler echo $54.42

93321 TC Doppler echo F/U or limited $19.82

93321 26 Doppler echo F/U or limited $7.57

93321 G Doppler echo F/U or limited $27.39

93325 TC Doppler color flow add-on $22.34

93325 26 Doppler color flow add-on $3.24

93325 G Doppler color flow add-on $25.59

93350 TC Stress TTE only $118.57

93350 26 Stress TTE only $72.80

93350 G Stress TTE only $191.37

93351 TC Stress TTE with exercise $149.56

93351 26 Stress TTE with exercise $87.21

93351 G Stress TTE with exercise $236.78

93352 G Use of contrast at stress $34.24

Echocardiography6

New January 1 2019!

Ultrasonography of the liver and urinary tact for vesicoureteral reflux6

CPT® code Description 2019 MPFS National Payment Rate

76978 Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-cardiac); initial lesion

TC: $247.9526: $82.89G: $330.84

+76979, add-on code Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-cardiac); each additional lesion with separate injection (List separately in addition to code for primary procedure)

TC: $180.92

26: $43.61

G: $224.52

INDICATIONS AND USAGE1

LUMASON is an ultrasound contrast agent indicated for use:• in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with

suboptimal echocardiograms• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patientsCONTRAINDICATIONS1

LUMASON is contraindicated in patients with:• history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1)].1

Please see full Prescribing Information for LUMASON ultrasound contrast agent including boxed WARNING at http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-informationYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS CARDIOPULMONARY REACTIONSSerious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)]. • Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)]. • Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].

MEDICARE NATIONAL AVERAGE PAYMENT RATES FOR PHYSICIAN OFFICE/IDTF

Page 13: 2019 LUMASON ULTRASOUND CONTRAST AGENT …...Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast

13

JW

PLEASE PRINT OR TYPE APPROVED OMB-0938-1197 FORM 1500 (02-1

10 01 18 10 01 18

93306 10 01 18 10 01 18

10 01 18 10 01 18 Q9950

LUMASON® Inj. Sulf hexa lipid microsphere/mL

XXXX XX 1

XXX XX 3

XXX XX 2 Q9950

Form Locator 19 & 24D: Global Billing Example F-19 – In order to facilitate coverage and payment, provide a description of the contrast drug (See Medicare contractors or private payer instructions for information required) F-24D – Enter CPT© or HCPCS Code for procedures performed and interpreted by physician

Form Locator 24G Enter the number of units based on the CPT© or HCPCS Code description Note: LUMASON® description is per mL

Bracco Diagnostics Inc. cannot guarantee coverage or payment for products or procedures at any particular level. For more specific information pleasecontact your Medicare contractor or the patient’s insurer.

JW ModifierApplied to the amount ofcontrast drug that is discarded

Sample physician billing global non-hospital outpatient setting CMS-1500Echocardiography with LUMASON

INDICATIONS AND USAGE1

LUMASON is an ultrasound contrast agent indicated for use:• in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with

suboptimal echocardiograms• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patientsCONTRAINDICATIONS1

LUMASON is contraindicated in patients with:• history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1)].1

Please see full Prescribing Information for LUMASON ultrasound contrast agent including boxed WARNING at http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-informationYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS CARDIOPULMONARY REACTIONSSerious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)]. • Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)]. • Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].

PHYSICIAN OFFICE & IDTF BILLING (cont’d)

Page 14: 2019 LUMASON ULTRASOUND CONTRAST AGENT …...Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast

14

Hospital in-patient billing: Medicare Severity Adjusted Diagnosis Related Groups (MS-DRG)7

ICD-10 procedure codes are used for in-patient billing. They indicate the surgical and/or diagnostic procedures performed on the patient. These codes, in combination with diagnosis codes, help determine the assignment to an MS-DRG payment category under Medicare and other payment systems. Payment in the hospital is determined by the MS-DRG. Under this system, a hospital is paid at a predetermined specific rate for each Medicare discharge. Fixed reimbursement is established for hospital services based on the patient diagnosis and is paid regardless of the actual cost the hospital incurs in providing the services. Ultrasound exams and contrast agents are part of the MS-DRG payment.

Coverage: Medicare National Coverage Decisions (NCD)Echocardiography is included in the Medicare NCD for ultrasound and is limited. There are Medicare Local Coverage Decisions (LCDs) for echocardiography with contrast.

The echocardiography LCDs can be found on the CMS website at: www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx.

The Medicare National Coverage Determination (NCD) for ultrasound is non-specific. Abdominal and retroperitoneal ultrasound are covered if medically appropriate.

Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 220.5 https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/ncd103c1_Part4.pdf

INDICATIONS AND USAGE1

LUMASON is an ultrasound contrast agent indicated for use:• in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with

suboptimal echocardiograms• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patientsCONTRAINDICATIONS1

LUMASON is contraindicated in patients with:• history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1)].1

Please see full Prescribing Information for LUMASON ultrasound contrast agent including boxed WARNING at http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-informationYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS CARDIOPULMONARY REACTIONSSerious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)]. • Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)]. • Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].

HOSPITAL IN-PATIENT BILLING AND COVERAGE

Page 15: 2019 LUMASON ULTRASOUND CONTRAST AGENT …...Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast

15

[email protected]

1-800-349-1388

How we support youThe Bracco Reimbursement Hotline is here to support you for all your reimbursement needs.

Ask coding and billing questions regarding Bracco Diagnostics products and procedures related to those products.

HCPCS codes for products

CPT® and HCPCS codes for procedures

Medicare payments

Monday-Friday: 9:00 AM-6:00 PM Eastern Time

References: 1. LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use full Prescribing Information. Monroe Twp, NJ: Bracco Diagnostics Inc., December 2016. 2. MLN Matter® 100923; October 2018 Update of the Hospital Outpatient Prospective Payment System (OPPS): https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10923.pdf. 3. American Medical Association. 2019 Professional Edition CPT® current procedural terminology. Chicago, IL: American Medical Association; 2018: 499 and 670-671. 4. American Medical Association. HCPCS Level II Professional 2019. Chicago IL: American Medical Association; 2019:147-148, 151. 5. CMS-1695-FC: Hospital Outpatient Prospective Payment- Notice of Final Rulemaking (NFRM) with Comment Period Year 2019. Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs. https://www.cms.gov/newsroom/fact-sheets/cms-finalizes-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center - Addendum B. 6. Centers for Medicare & Medicaid Services. Physician Fee Schedule Look-Up Tool. Centers for Medicare & Medicaid Services Web site. www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PFSlookup/index.html. Accessed January 3, 2019. 7. Centers for Medicare & Medicaid Services. Acute Care Hospital Inpatient Prospective Payment System. Washington, DC: Centers for Medicare & Medicaid Services, Department of Health and Human Services. www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/AcutePaymtSysfctsht.pdf. Published December 2016. Accessed January 3, 2019.

✓✓✓

INDICATIONS AND USAGE1

LUMASON is an ultrasound contrast agent indicated for use:• in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with

suboptimal echocardiograms• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patientsCONTRAINDICATIONS1

LUMASON is contraindicated in patients with:• history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1)].1

Please see full Prescribing Information for LUMASON ultrasound contrast agent including boxed WARNING at http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-informationYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS CARDIOPULMONARY REACTIONSSerious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)]. • Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)]. • Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].

For more information on reimbursement, contact the Bracco Reimbursement Hotline at:

REIMBURSEMENT HOTLINE

Page 16: 2019 LUMASON ULTRASOUND CONTRAST AGENT …...Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast

Ordering information

NDC# 0270-7099-16

Product description

LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use, 25 mg/vial

Packaging 5 kits per box

Bracco Diagnostics Inc.259 Prospect Plains Road, Building HMonroe Township, NJ 08831 USAPhone: 609-514-2200Toll Free: 1-877-272-2269 (U.S. only)Fax: 609-514-2446

©2019 Bracco Diagnostics Inc. All Rights Reserved.

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LUMASON is manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831 by Bracco Suisse S.A., Plan-les-Ouates Geneve, Switzerland (LUMASON lyophilized powder vial-25 mg lipid-type A/60.7 sulfur hexafluoride gas); Vetter Pharma-Fertigung GmbH & Co. KG, 88212 Ravensburg, Germany (Sodium Chloride 0.9% Injection, USP); B. Braun Melsungen AG, 34212 Melsungen, Germany (Mini-Spike).

LUMASON is a registered trademark of Bracco Diagnostics Inc.

Customer Service: 1-877-BRACCO9 (1-877-272-2269)

INDICATIONS AND USAGE1

LUMASON is an ultrasound contrast agent indicated for use:• in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with

suboptimal echocardiograms• in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients• in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patientsCONTRAINDICATIONS1

LUMASON is contraindicated in patients with:• history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON

The risk for serious cardiopulmonary reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see Warnings and Precautions (5.1)].1

Please see full Prescribing Information for LUMASON ultrasound contrast agent including boxed WARNING at http://www.braccoimaging.com/us-en/products-and-solutions/contrast-enhanced-ultrasound/lumason/prescribing-informationYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS CARDIOPULMONARY REACTIONSSerious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1)]. • Assess all patients for the presence of any condition that precludes administration [see Contraindications (4)]. • Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1)].

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LUMASON ORDERING INFORMATION